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InterMune Receives FDA Complete Response Letter on Esbriet(TM) (Pirfenidone) New Drug Application
Date:5/4/2010

ad submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA), seeking approval to market Esbriet for the treatment of IPF patients in the European Union.  Esbriet (pirfenidone) has been granted Orphan Drug status for the treatment of IPF in Europe.

About Esbriet (pirfenidone)

In February 2009, InterMune announced the results of the company's two global Phase 3 clinical trials evaluating Esbriet for the treatment of IPF, known as the CAPACITY trials.  Prior to the CAPACITY results, a Phase 3 study in IPF patients was conducted in Japan by Shionogi & Co. Ltd. which led to the marketing approval of pirfenidone in Japan in October of 2008.  In these clinical studies, Esbriet was safe and generally well tolerated with the most frequent side effects reported being photosensitivity rash and gastrointestinal symptoms.

About IPF

Idiopathic pulmonary fibrosis (IPF) is a progressive, debilitating and ultimately fatal disease that affects approximately 200,000 people in Europe and the United States combined, with approximately 30,000 new cases reported per year in each region.

IPF is characterized by inflammation and scarring (fibrosis) in the lungs, hindering the ability to process oxygen and is a progressive disease, meaning that over time, lung scarring and symptoms increase in severity.  The median survival time from diagnosis is two to five years, with a five-year survival rate of approximately 20%.  Patients diagnosed with IPF are usually between the ages of 40 and 70, with a median age of 63 years and the disease tends to affect slightly more
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SOURCE InterMune, Inc.
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